Rohit Bhattacharjee, Amity University, Kolkata.
The GACVS COVID-19 Vaccine Safety subcommittee met virtually on Tuesday, January 2021, to review available information and data of mortalities reported in frail, elderly individuals who had received the Pfizer BioNTech COVID-19 mRNA vaccine, BNT162b2 (hereafter, BNT162b2). Experts invited from the European Medicines Agency (EMA) and therefore the Uppsala Monitoring Centre (UMC) provided a summary of deaths reported in Europe and within the WHO global database (VigiBase) following vaccination with BNT162b2. Backing up by a careful scientific review of the knowledge made available, the subcommittee came to the subsequent conclusions:
- The present reports don’t suggest any unexpected or untoward increase in fatalities in frail, elderly individuals or any unusual characteristics of adverse events following administration of BNT162b2. Reports are in line with the expected, all-cause mortality rates and causes of death within the sub-population of frail, elderly individuals, and therefore the available information doesn’t confirm a contributory role for the vaccine within the reported fatal events.
- Insight of this, the committee considers that the benefit-risk balance of BNT162b2 remains favorable within the elderly, and doesn’t suggest any revision, at the present, to the recommendations around the safety of this vaccine.
- Countries should be still monitoring the security of vaccines, and promote routine after-care following immunization, according to good immunization practices for any vaccine. The committee recommends that data on suspected adverse events should be collected and reviewed continuously – nationally, regionally, and globally – because the COVID-19 vaccines are unrolled, world-wide. The GACVS subcommittee will still monitor the security data from these vaccines and update any advice as necessary.
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